Bypass Versus Endovascular Procedure in Long Lesions of the Superficial Femoral Artery in the Claudicant
NCT ID: NCT05216731
Last Updated: 2025-10-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
290 participants
INTERVENTIONAL
2025-01-20
2030-05-20
Brief Summary
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There is a current low level of evidence for the treatment modalities of long lesions (15-25 cm) of the superficial femoral artery and in particular no clinical trial comparing the femoro-popliteal bypass to the endovascular procedure whose patency in retrospective series. appears lower than that of surgery but nevertheless appears in the European recommendations for first-line treatment, with the absence of a dedicated trial being highlighted.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Bypass group
Under general or local anesthesia: Use of the best vascular substitute (inverted saphenous vein or vascular prosthesis).
Femoro-popliteal bypass
Under general or local anesthesia: Use of the best vascular substitute (inverted saphenous vein or vascular prosthesis).
Endovascular procedure group
Under general anesthesia, local anesthesia or sedation: Performing a balloon angioplasty completed by preferred stent deployment or drug-coated balloon angioplasty.
Endovascular procedure
Under general anesthesia, local anesthesia or sedation: Performing a balloon angioplasty completed by preferred stent deployment or drug-coated balloon angioplasty.
Interventions
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Femoro-popliteal bypass
Under general or local anesthesia: Use of the best vascular substitute (inverted saphenous vein or vascular prosthesis).
Endovascular procedure
Under general anesthesia, local anesthesia or sedation: Performing a balloon angioplasty completed by preferred stent deployment or drug-coated balloon angioplasty.
Eligibility Criteria
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Inclusion Criteria
* Effective contraception for the duration of research for fertile women of childbearing age
* Unilateral Rutherford 2 or 3 symptomatic Lower Extremity Artery Disease (LEAD) arteritic patient with a lesion of the superficial femoral artery Trans-Atlantic Inter-Society Consensus (TASC) C or D between 15 and 25 cm
* Patient eligible for bypass surgery and endovascular procedure
* No alteration of the upstream flow (iliac flow preserved or restored)
* Patient with at least one patent artery below the knee
* Patient informed and having signed the information and consent form to participate in the study
Exclusion Criteria
* Iliac flow altered upstream
* History of surgery or stent on the affected superficial femoral artery
* Concomitant bacteremia (positive blood cultures in the 7 days preceding the procedure)
* Known intolerance to antiaggregants or heparin
* Contraindication to the endovascular procedure (severe renal failure contraindicating the injection of contrast product despite prior hydration, known severe allergy to iodinated contrast product \[unless the center chooses to use carbon dioxide injection\]) or bypass surgery (cardiovascular, respiratory or other comorbidities, contraindicating general anesthesia, local contraindications for bypass: skin lesion at the operative site)
* No affiliation to a social security regime or to another social protection regime
* Patient deprived of liberty or under legal protection (guardianship, trusteeship)
* Inability, according to the investigator, to understand or refusal to sign the informed consent to participate in the study (non-French speaking patient, cognitive disorders)
* Ongoing participation in another research protocol Participation in non-interventional research is authorized
Secondary exclusion criterion:
* Negative opinion from the anesthesiologist-resuscitator at the end of the pre-anesthetic consultation
* Positive pregnancy test from the pre-operative laboratory test (result received after obtaining consent, but before the surgical procedure)
18 Years
ALL
No
Sponsors
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Assistance Publique - Hôpitaux de Paris
OTHER
Responsible Party
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Principal Investigators
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Joseph TOUMA, MD, PhD
Role: STUDY_DIRECTOR
Assistance Publique - Hôpitaux de Paris
Locations
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CHU - Hôpitaux de Bordeaux
Bordeaux, , France
Hôpital Ambroise Paré, APHP
Boulogne-Billancourt, , France
Hôpital de la Cavale Blanche
Brest, , France
Centre hospitalier René Dubos
Cergy-Pontoise, , France
Hôpital Henri Mondor, APHP
Créteil, , France
Hôpital François Mitterrand
Dijon, , France
Hôpital Edouard Herriot
Lyon, , France
Hôpital de la Timone, APHP
Marseille, , France
CHU de Nice
Nice, , France
CHU Carémeau
Nîmes, , France
Hôpital Européen Georges Pompidou, APHP
Paris, , France
Hôpital Bichat - Claude Bernard, APHP
Paris, , France
Hôpital La Pitié-Salpêtrière, APHP
Paris, , France
CHU de Poitiers
Poitiers, , France
CHU de Rangueil
Toulouse, , France
Institut Lorrain du Cœur et des Vaisseaux Louis Mathieu
Vandœuvre-lès-Nancy, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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APHP191106
Identifier Type: -
Identifier Source: org_study_id
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